Clinical Trials On Bio
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Regulatory Approval Of Clinical Studies In The Netherlands
5/16/2013
The EU Clinical Trials Directive (CTD) has been fully implemented in the Netherlands.
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Global Biosimilar Development
5/16/2013
Inconsistency in nomenclature used for biosimilars has led to confusion in referring to some products.
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Moving Towards An Electronic Environment In Clinical Trials
5/3/2013
With each passing year, clinical trials are becoming increasingly global. The business of product development is moving away from the traditional model in which studies are conducted primarily in the US – in fact, recent estimates indicate that within the next three years, up to 65 per cent of studies under FDA regulation will be conducted outside the US. A review of a US government clinical trials registry and of 300 published reports in major medical journals revealed that one third (157 of 509) of Phase III trials were being conducted entirely outside the US, with over half the study sites (13,521 of 24,206) used in these trials located overseas, many in eastern Europe and Asia.
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CFS Clinical Helps Top 20 Pharma Improve Investigator Payment And Budget Management While Addressing Sunshine & FMV Compliance
3/19/2013
Like its peers of all sizes operating in the United States, this Top 20 Pharma has faced the challenge of anticipating and addressing the Physician Payment Sunshine Provision (PPSP) within the Patient Protection and Affordable Care Act (PPACA) of 2009. Presented By Jim DiCesare, VP and General Manager, Contract and Regulatory Services
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Improve Investigator Payment and Budget Management While Addressing Sunshine & FMV Compliance
2/11/2013
Like its peers of all sizes operating in the United States, this Top 20 Pharma has faced the challenge of anticipating and addressing the Physician Payment Sunshine Provision (PPSP) within the Patient Protection and Affordable Care Act (PPACA) of 2009. By CFS Clinical
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Grant Payment Practices: Five Requirements For Stronger Investigator Relationships
9/27/2012
In the clinical trials industry, profitability and regulatory compliance pressures continue to mount. Consequently, pharmaceutical companies are striving to maximize their research and development spending by reducing clinical trial cycle times and focusing on their core competencies—all while maintaining high standards of quality. By James M. Dicesare and Kevin T.Williams, Clinical Financial Services, LLC (CFS).
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Leveraging Investigator Grant Payment Practices To Enhance Sponsor-Site Relationships
9/19/2012
One of the world’s leading pharmaceutical companies, AstraZeneca, has over 67,000 employees. Among those are about 13,000 at 17 principal research and development centers in eight countries — including the United States.
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Persistence Leads To High Enrollment: PRA Convinces Client To Stick With Recruitment Strategies
2/21/2012
PRA was contracted by a large biotech client to evaluate the immunogenicity of a flu vaccine in adult subjects with rheumatoid arthritis. From the start, the PRA study team faced a shortened enrollment period and other timeline challenges, including the protocol’s late delivery as well as problems with the vaccine’s availability.
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PRA Exceeds Tough Enrollment Goals: Service Delivery Model Drives Positive Results
2/20/2012
Changes in resources for both the client and PRA teams led to significant challenges with the start-up and enrollment activities in Europe and North America.
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Human ADME & Studies With Radiolabeled Compounds
During clinical drug development there can be several situations where the use of radiolabeled medication or other radiolabeled compounds is required or favorable to accomplish the study objectives. This whitepaper is mainly focusing on human ADME studies and “microdose” studies to assess absolute bioavailability (BA). The major part of the information in this overview is also relevant for other clinical studies with a radiolabeled compound. By Ad Roffel and Henk Poelman, PRA Health Sciences